Pall International Sàrl

Address:Ave de Tivoli 3,Fribourg,CH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Filter, blood, cardiopulmonary bypass, arterial line (DTM) (3) Syringe, piston (FMF) (3) Filter, infusion line (FPB) (2) APPARATUS, EXHAUST, SURGICAL (FYD) (1) CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE (JQC) (1)

Premarket Exempt

Yes No

Clear

Pall LeukoGuard LG - 05034480000392 Catalog Number : LG6

Device Description : Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service

Device Class : 2

Duns Number: 485050483

Premarket Exempt : No

Product Code : DTM

Prescription Use : Yes

Device Count : 1

Pall LeukoGuard LG - 05034480000408 Catalog Number : LG6B

Device Description : Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service (with Bypass Loop)

Device Class : 2

Duns Number: 485050483

Premarket Exempt : No

Product Code : DTM

Prescription Use : Yes

Device Count : 1

Pall® Oxygenator Gas Line Filter - 05034480000446 Catalog Number : ORO1H

Device Description : Bi-directional oxygenator gas line filter for use in gas lines and is indicated Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen and other medical gases.

Device Class : 1

Duns Number: 485050483

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

Pall Supor® AEF Filter - 05034480104373 Catalog Number : AEF1E

Device Description : 0.2 micron air eliminating filter with low protein binding Supor membrane for up 0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use.

Device Class : 2

Duns Number: 485050483

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Pall LeukoGuard BC2 - 05034480306104 Catalog Number : BC2B

Device Description : Pall LeukoGuard BC2 Blood Cardioplegia Filter

Device Class : 2

Duns Number: 485050483

Premarket Exempt : No

Product Code : DTM

Prescription Use : Yes

Device Count : 1

Pall Supor® AEF Filter - 05034480308825 Catalog Number : AEF1NTE

Device Description : 0.2 micron air eliminating filter with low protein binding Supor membrane for up 0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use. Without attached extension tubing.

Device Class : 2

Duns Number: 485050483

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Pall PharmAssure® Syringe Filter - 05034480308924 Catalog Number : HP1002

Device Description : 25 mm syringe filter with 0.2 micron low protein binding Supor membrane

Device Class :

Duns Number: 485050483

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 50

Pall PharmAssure® Syringe Filter - 05034480308931 Catalog Number : HP1050

Device Description : 25 mm syringe filter with 5.0 micron low protein binding Supor membrane

Device Class :

Duns Number: 485050483

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 50

Pall PharmAssure® Syringe Filter - 05034480308948 Catalog Number : HP1012

Device Description : 25 mm syringe filter with 1.2 micron low protein binding Supor membrane

Device Class :

Duns Number: 485050483

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 50

Pall LaparoShield® Plus Laparoscopic Smoke Filtration System - 05034480308979 Catalog Number : LSF1

Device Description : Laparoscopic Smoke Filtration System

Device Class : 2

Duns Number: 485050483

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

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